Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364462
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-12
Brief Title:
Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is an observational study of NASH patients with a calculated sample size of 220 Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention Patients will be followed up at baseline and every six months with h-CRP liver function tests fasting blood glucose fasting insulin ferritin liver ultrasonography and liver stiffness measurements
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None